Overview
The goal of this clinical investigation is to learn if the Recana Thrombectomy Catheter System can treat chronic venous obstruction and occlusion in participants with symptomatic post-thrombotic venous inflow/outflow obstruction. The main questions the clinical investigation aims to answer are:
- primary safety endpoint: procedural events defined as the rates of all adverse events occurring up to 30 days post-index procedure
- primary efficacy endpoint: percent (%) lumen gain during the index procedure, which is measured using intravascular ultrasound (IVUS) at the time of the procedure
Participants are screened and qualified for the clinical investigation. Qualified participants (those that meet all eligibility criteria) will undergo treatment with the Recana Thrombectomy Catheter System. Participants are assessed at the following timepoints: 30, 90, 180 and 365 days post-procedure.
Description
STUDY DESIGN: The RECANA Study is a prospective, non-randomized, safety and performance (efficacy) study to evaluate participants treated with the Recana Thrombectomy Catheter System for the treatment of symptomatic post-thrombotic venous inflow/outflow obstruction.
STUDY OVERVIEW: Potential participants who pass pre-screening and are willing to participate in the study will be asked to sign the study Informed Consent Form before any study-specific tests or procedures are performed or for any study specific evaluations not considered standard of care that need to be performed to assess eligibility.
Eligible participants may undergo the index procedure. Adverse events are assessed starting on the day of the index procedure (considered Time 0) through 365 days post-procedure. All participants enrolled in the study are evaluated at screening/baseline, index procedure through hospital discharge, 30-days, 90-days, 180 days and 365 days post-procedure. Duplex ultrasound, clinical assessments, quality of life, adverse events and concomitant medications are assessed at each follow-up visit.
STUDY POPULATION: Patients with symptomatic post-thrombotic venous inflow/outflow obstruction.
STUDY ENROLLMENT: Enrollment in the study is expected to take approximately 6-9 months. Follow up will continue through 12 months, therefore, the duration of the study is approximately 18-21 months.
Eligibility
Inclusion Criteria:
- Provision of signed and dated informed consent form;
- Participant is 18 years of age and older;
- Neurologically stable;
- Ambulatory;
- Symptomatic chronic venous insufficiency (CVI), with edema or pain, (CEAP classification of C3 or greater);
- Flow-limiting venous outflow obstruction (>50%) within the intended target sites, defined by (a) a common femoral vein continuous waveform without respiratory variation on duplex ultrasound, or, (b) complete occlusion of any part of the iliofemoral tract as diagnosed on baseline duplex or axial imaging per local protocol; and
- Target treatment IVC/Common Iliac confluence to the deep veins above the knee.
Exclusion Criteria:
- Comorbidity risks which may limit longevity (<2 years life expectancy), would preclude open surgery, or would significantly increase risk for venous thrombo-embolism (VTE);
- Invasive abdominal, pelvic or peripheral vascular surgery within 90 days of the procedure;
- History of stroke within the last 6 months;
- Known hypercoagulable states that, in the opinion of the Investigator, cannot be medically-managed throughout the study period (i.e., known thrombophilia) including Heparin-induced thrombocytopenia (HIT) and antiphospholipid syndrome (APS);
- Interventional procedure in the deep venous system (including stent placement) in the target limb or outflow vessels within 6 weeks of consent;
- Acute deep venous thrombosis (DVT) in the index limb (not previously observed in the thrombus bearing segment) within 3 months of consent;
- Inadequate inflow in the opinion of the investigator, that cannot be improved to the target vessel;
- Flow-limiting venous outflow obstruction central to the target/treatment vessel that cannot be treated;
- Pregnant and/or breastfeeding;
- Patients with cognitive impairments who are unable to be consented;
- Patient is enrolled in another clinical study that, in the opinion of the Investigator, may conflict with this study or compromise study results;
- COPD or similar conditions (lung cancer, pulmonary hypertension, prior major lung surgery, emphysema, O2 dependency) that may, in the opinion of the investigator result in higher pulmonary risk; and
- Patients considered to belong to a vulnerable population.